1. Field of the Invention
The invention herein relates to the collection and analysis of body fluid samples, especially blood samples, from humans or animals. More particularly it is related to devices used for such collection and analysis.
2. Description of the Prior Art
The health care industry relies on the donation of blood and plasma by many thousands of people each year. For each blood donor, a health care professional performs a venipuncture and drains a pint (or half-liter) of blood through a length of transfer tubing and into a flexible plastic bag. Plasma typically is collected into a bottle, with red blood cells being returned to the donor. The resulting filled bag or bottle is known as a xe2x80x9cunitxe2x80x99 of blood or plasma,
After collection, each unit of blood or plasma must be tested for several infectious organisms, including the human immunodeficiency virus (HIV) and several types of hepatitis. Other tests may be performed as well. To perform these tests, a sample must be removed from each unit of collected blood or plasma. Each sample is then labeled, to identify the unit from which it was drawn, and sent to a laboratory for analysis.
Many techniques and devices are available to make these analyses. The particular ones used may vary with the substances of concern to the blood bank operator, the researcher, or whichever other party intends to use the product. Blood analyzers may range from small xe2x80x9cper dropxe2x80x9d analysis devices to large laboratory equipment capable of rapidly analyzing a large number of samples.
If the laboratory tests performed detect the presence of an infectious disease or other contaminant in the sample, the unit from which the sample was drawn must be identified and discarded. Personnel at the blood storage facility are responsible for matching the tested samples with their original units and correctly selecting the tainted units for disposal.
Clearly, this procedure requires considerable care and attention from everyone in the systemxe2x80x94those who draw and label the samples, those Who issue the test results, and especially those who match the test results to the original units.
Unfortunately, although the system functions smoothly most of the time in the United States, on occasion a tainted unit of blood still finds its way into the blood pool and, eventually, into a patient who leaves the hospital with an incurable disease that he did not have when he entered the hospital. It should be mentioned that many Third World countries have too few resources to perform any screening tests at all on blood or plasma before delivering it to the end user. Consequently, although even the small degree of error encountered in the American system is unacceptable, the amount of risk incurred in other areas of the world may be staggering.
The same processxe2x80x94with the same risksxe2x80x94applies to veterinary blood supplies as well. The result of this potential for infected or contaminated blood products to be unknowingly administered to previously uninfected recipients has created a significantxe2x80x94and justifiedxe2x80x94level of anxiety among members of the public and among health care professionals responsible for ordering and administering these products.
Similar problems arise in the collection and analysis of other body fluids, such as urine, lymph, bile, pleural fluid, ascites fluid, stomach and intestinal fluids, colostrom, milk, and the like. While the principal emphasis in the medical field has been upon blood and blood plasma collection, because of the vast quantities collected, provision of secure collection and analysis means for other body fluids is also important and of significant interest.
Secure collection must also be followed by protection of the sample against subsequent contamination, either by handling or by the analysis testing itself. Even such acts as exposure of the sample to ambient air can introduce contaminants into the sample.
Further, whether with blood or other body fluids, it is important to have a long term record available of the properties of each sample obtained. Usually this is done for the most part by the keeping of written sample analysis records. However, written records can be misplaced or destroyed, or, most importantly, can be recognized or suspected of being incorrect. It would therefore be advantageous to have an analysis and collection/containment device which would maintain a drawn body fluid sample and its analyses in essentially permanent physical form, so that the sample and its analyses can be visually checked at a later date if written records are absent or of doubtful accuracy.
There have been devices described as useful for analysis of blood and related bodily fluids and which incorporate a test device in some manner with a collection bag or vial. See, for instance, U.S. Pat. Nos. 4,820,297; 4,846,005; 4,900,321 and 5,595,187. Such devices have not proved successful or workable for many types of blood or fluid analysis, however, since they lack features such as maintenance of permanent unaltered samples of the blood or other fluid, they do not provide for controls to confirm that the device is operating properly, or they permit contact of the sample with the ambient atmosphere or other source of contaminants.
We have now developed a single, integrated device in which a body fluid (e.g., blood) can be both collected and analyzed easily without risk of contamination. The transfer of the body fluid between the collection portion and analysis portion of the device is through a unique structure designed to permit movement of small quantities of body fluid under controlled conditions, to minimize any waste of the body fluid and to ensure that no contamination reaches the main fluid volume. The device also is permanently associated with the collection container and retains a significant quantity of the blood or other fluid in a contamination- or reaction-free condition, so that tests can be repeated at subsequent periods with consistent and reliable results. Further, control means are incorporated into the device to provide assurance the when in operation the device contains a sufficient quantity of the fluid for accurate analysis, and that the testing reagents in the device are operating accurately.
A wide variety of different body fluid components which may be indicative of various diseases, dysfunctions and abnormalities of the patient or the body fluid itself can be analyzed. In some embodiments the device is entirely hand manipulated such that the device can be used in any location, even where no external sources of power or other mechanical or electrical aids are available. In other embodiments the operation of the device can be with mechanical or electrical pumping components. The device is thus ideal for use in the field for emergency and preliminary analysis of a patient""s condition, thus allowing field medical personnel to deal with such conditions as appropriate long before the patient can be transferred to more extensive medical facilities, as well as in regular blood banks and research laboratories where analysis can be substantially automated.
The device is also useful for veterinary purposes. By appropriate selection of the testing and analysis sensors to be used, body fluid drawn from animals can be rapidly analyzed, such that, for instance, a diseased animal in a herd can be quickly identified and isolated from the other animals to prevent the spread of infection within the herd. The ability to use the device in the field is of significant advantage in veterinary use, since in many cases the animals are in remote locations far from veterinary medical facilities, or it is difficult or impractical to transport the animals to such facilities.
Of particular significance with the present device is that its structure and operation ensure that the main portion of the body fluid unit drawn from the patient or donor remains isolated within the collection container during transfer of the test sample and cannot be contaminated by external contaminants, by backflow of the test sample, by transfer of testing chemicals, by contamination from improper handling of the test sample or incorrect operation of the analysis equipment, or by malfunction of the transfer or analysis equipment.
Further, because the collection container and the analysis device are permanently joined, the fluid sample and its analyses remain physically available well into the future, such that if any question subsequently arises about the properties of the sample or the analyses observed, which question cannot be answered unequivocally by the written records, the sample and the analysis units can be physically inspected and the original results verified.
The permanent combination of the collection/retention container for the bodily fluid and the testing device, with prevention of return of any portion of the fluid withdrawn from the container for testing in the testing device, is a critical element in the success of this device. Other products presently available, or which have been available in the past, while providing containment or testing, have not been the equivalent of this invention. Only with the permanent, sealed, connected structure of the present device can there be assurance that the bodily fluid sample remains uncontaminated from any source, including airborne materials, and that the test results always remain directly and permanently with the sample and its container. It is imperative in medical testing, such as blood testing, that tests of a fluid sample remain available for retesting or for confirmation of prior results, and that there be no possibility that test results for a particular sample be misfiled, misidentified or mistaken for results of a different sample. While prior art systems which involve separate of sample and test results, i.e., those in which the testing device is removable from the container, purport to be reliable in maintaining absolute identification between the sample and the test results, errors by laboratory personnel are not uncommon, labels on separated containers and test kits can come off or be rendered illegible, and many other events can occur which makes it difficult or impossible to match a bodily fluid sample and its test results once they have been separated. Such occurrences are impossible with the present invention, since the sample in its container and the test results in the testing unit are permanently joined and cannot be separated. Consequently the laboratory, the patient, the physician, and all others involved with patient care or treatment can be assured that future reference to the bodily fluid sample will find the sample uncontaminated for inspection or if further sample withdrawals are required and the original test results unequivocally associated with the sample.
Thus, not only does the present device provide a fast, easy and economical way of collecting and analyzing blood on a unit by unit basis, but it also ensures that the analysis itself, including the transfer of test sample to the analyzer, does not put the main body of the fluid unit at risk.
Therefore, the device of the present invention will be seen to be an integrated assembly that contains a bag, bottle, or other container for collecting human or animal body fluid, especially blood or plasma; one or more testing chambers containing one or more analysis units activated by the body fluid; a manual or automated pump or vacuum assembly to transfer one or more samples into one or more analysis units; and one-way valves or the equivalent to prevent any portion of the withdrawn sample from being returned to the volume of body fluid in the collection container. In one embodiment there is a pump or vacuum assembly between the main collection container and the testing chamber(s). Means are also present to insure that the device is properly filled with fluid and that the fluid is being analyzed correctly. In another embodiment the testing chamber(s) lies between the main collection container and a pump or vacuum assembly.
Thus, in a broad embodiment, the invention is of a body fluid collection and analysis device for analysis of a body fluid comprising a body fluid reservoir; a body fluid-activated analysis unit permanently associated therewith; a fluid conduit between the reservoir and the analysis unit for passage of the body fluid from the reservoir to the analysis unit; transfer means for transferring the body fluid from the reservoir to the analysis unit through the fluid conduit; and a backflow restrictor in the fluid conduit; such that no portion of body fluid transferred by the pump from the reservoir to the analysis unit returns to the reservoir.
The body fluid acted upon may be, but is not limited to, blood, blood plasma, urine, bile, pleural fluid, ascites fluid, stomach or intestine fluid, colostrom, milk or lymph.
The transfer means may be a mechanical or electromechanical pump or a vacuum fluid drawing assembly.
The analysis unit may contain a single detector for detecting the presence or absence of a single component of the body fluid which may be indicative of various diseases, dysfunctions and abnormalities of the patient or the body fluid itself. Alternatively, there may be a plurality of such detectors, each of which is configured with appropriate reactants to detect and indicate the presence or absences of different respective components of the body fluid which may be indicative of various diseases, dysfunctions and abnormalities of the patient or the body fluid itself.
Other embodiments will be described expressly below or will be evident from the descriptions below.